Bipolar disorder measures in clinical care

临床护理中的双相情感障碍措施

• 批准号: 10426702
• 负责人: Joseph M. Cerimele
• 金额: $ 24.92万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-03-18 至 2025-02-28
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10426702
• 关键词: Adoption; Bipolar Disorder; Caring; Clinic; Clinical; Clinical assessments; Consensus; Country; Data; Development; Diagnosis; Effectiveness; Goals; Health Care Quality Assurance; Impairment; Individual; Joints; Literature; Manic; Measurement; Measures; Mental Depression; Mental disorders; Monitor; National Committee for Quality Assurance; National Institute of Mental Health; Outcome; Outcome Measure; Patient Care; Patient Self-Report; Patient-Focused Outcomes; Patients; Persons; Population; Positioning Attribute; Property; Protocols documentation; Psychometrics; Qualitative Methods; Quality of life; Randomized; Recommendation; Relapse; Research; Severities; Standardization; Strategic Planning; Surveys; Symptoms; System; Testing; Time; Uncertainty; Work; arm; base; behavioral health; clinical care; clinical decision-making; clinical practice; compare effectiveness; depressive symptoms; effectiveness trial; experience; health care service organization; health organization; improved; instrument; programs; randomized effectiveness trial; randomized trial; routine care; standard of care; systematic review; treatment as usual; treatment response; trial comparing; uptake

The proposed project goal is to determine which validated bipolar disorder instrument is most acceptable and helpful to patients and clinicians in clinical care, demonstrate that the preferred instrument can be used to monitor outcomes with high fidelity in routine care, and assess the feasibility of comparing effectiveness of measurement-based care (MBC) to usual care in a randomized trial. Many individuals with bipolar disorder experience fluctuating depressive and manic symptoms which can impair functioning and reduce quality of life. Measurement based care (MBC) is an emerging best practice involving serial assessment of clinical status and using those findings to inform clinical decision making. When implemented with fidelity, MBC helps clinicians adjust treatment to “treat to target”. However, no studies have determined preferred bipolar disorder measures for use in clinical care. Furthermore, adoption of MBC for individuals with bipolar disorder has had especially low uptake in routine care. The lack of consensus about which measure to use in serial assessment of bipolar disorder clinical status is likely due to the difficulty of assessing clinical status for patients with bipolar disorder. There are multiple ways to measure clinical status including measuring functioning or symptoms, and when measuring symptoms, there is a need to measure changes in both depressive and manic symptoms. Specifically, there may be uncertainty about how to interpret symptom scale results with respect to weighing the importance of depression and manic symptom severity (particularly when they vary in opposite directions between time points). There is a need to determine the optimal measure for use in MBC for individuals with bipolar disorder. Aims of this R34 include: 1) Using qualitative methods, obtain input from people with bipolar disorder to choose the preferred instrument for monitoring bipolar disorder clinical status that is acceptable, helpful, and understandable in informing when to change treatment. In Aim 1 we expect to identify an Identify an MBC instrument that is perceived to be acceptable, helpful, and understandable to patients diagnosed with bipolar disorder. Next, in Aim 2) In a single arm open trial, assess the feasibility of MBC with the preferred instrument for bipolar disorder and assess fidelity to the protocol including instrument administration, scoring, and reviewing results. In Aim 2 we expect to achieve high fidelity to the MBC protocol. In Aim 3) Conduct a randomized pragmatic pilot effectiveness trial comparing the MBC with the preferred instrument for bipolar disorder to usual care. We will test the Aim 3 hypothesis that treatment adjustments will occur more often in the MBC group than the usual care group, and the exploratory hypothesis that symptoms of bipolar disorder will decrease more in the MBC group than the usual care group. These findings will support an R01 application to conduct a definitive randomized trial.

拟议的项目目标是确定哪种经验证的双相情感障碍仪器最 在临床护理中，患者和临床医生可接受并有帮助，证明首选 该仪器可用于在常规护理中高保真地监测结果，并评估其可行性 在一项随机试验中比较基于测量的护理（MBC）与常规护理的有效性。 许多患有双相情感障碍的个体经历波动性抑郁和躁狂症状， 可能会损害功能并降低生活质量。基于测量的护理（MBC）是一个新兴的最佳 涉及临床状态的系列评估并使用这些结果为临床决策提供信息的实践 制作。当以保真度实施时，MBC帮助临床医生调整治疗以“治疗目标”。 然而，没有研究确定用于临床护理的首选双相情感障碍措施。 此外，采用MBC治疗双相情感障碍患者的吸收率特别低， 常规护理关于在双相情感障碍的系列评估中使用哪种测量方法缺乏共识 疾病临床状态可能是由于难以评估双相患者的临床状态 disorder.有多种方法来测量临床状态，包括测量功能或 症状，当测量症状时，需要测量抑郁和抑郁症的变化。 和躁狂症状具体而言，可能存在关于如何解释症状量表的不确定性 结果关于衡量抑郁症和躁狂症状严重程度的重要性（特别是 当它们在时间点之间沿相反方向变化时）。需要确定最佳 用于双相情感障碍患者MBC的测量。R34的目标包括：1）使用 定性方法，从双相情感障碍患者那里获得输入，以选择首选工具 用于监测双相情感障碍的临床状态，这是可接受的，有帮助的，可以理解的， 告知何时改变治疗。在目标1中，我们希望确定一种MBC工具， 被诊断为双相情感障碍的患者认为是可接受的、有帮助的和可理解的。 接下来，在目标2）中，在单组开放试验中，评估使用首选工具进行MBC的可行性， 双相情感障碍，并评估对方案的忠诚度，包括仪器管理，评分， 审查结果。在目标2中，我们期望实现对MBC协议的高保真度。目标3）进行 比较MBC与首选工具的随机实用性试点有效性试验， 双相情感障碍的常规护理。我们将检验目标3假设，即治疗调整将发生 MBC组比常规护理组更常见，并且探索性假设症状 MBC组的双相情感障碍的发生率比常规护理组下降更多。这些发现将 支持R01申请进行确定性随机试验。